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Oncology. 2005;69(5):372-83. Epub 2005 Nov 24.

Five-year update of an expanded phase II study of dose-dense and -intense doxorubicin, paclitaxel and cyclophosphamide (ATC) in high-risk breast cancer.

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1
Jersey Shore University Medical Center, Neptune, N.J., USA.

Abstract

OBJECTIVES:

This study evaluated the safety and efficacy of dose-dense and -intense sequential doxorubicin (A), paclitaxel (T) and cyclophosphamide (C) as adjuvant therapy for breast cancer (BC) with >or=4 ipsilateral axillary lymph nodes.

METHODS:

Patients were recruited after BC surgery if >or=4 axillary nodes were involved by metastatic cancer. Planned treatment was A 90 mg/m(2) three times every 14 days (q14d x 3), T 250 mg/m(2) q14d x 3 and C 3 g/m(2) q14d x 3 combined with filgrastim support.

RESULTS:

The study enrolled 85 eligible patients. The median number of lymph nodes involved was 9. Mean dose intensity was >94% of planned for each drug. Common grade 3 toxicities included nausea and/or vomiting (24%), mucositis (18%), neuropathy (16%), palmar-plantar erythrodysesthesia (12%), myalgia (6%) and arthralgia (6%). Grade 3/4 neutropenia occurred in 77 (91%) patients, and 32 (38%) patients had neutropenic fever. One patient developed acute leukemia. Sixty-nine (81%) patients are alive, and 59 (69%) patients are alive and free of distant disease at a median follow-up of 5 years.

CONCLUSIONS:

ATC is a feasible regimen for adjuvant therapy of high-risk BC, with a relatively low rate of relapse at the 5-year follow up.

PMID:
16319508
DOI:
10.1159/000089991
[Indexed for MEDLINE]
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